Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants

<p>Abstract</p> <p>Background</p> <p>Maintenance treatment with antidepressants is the leading strategy to prevent relapse and recurrence in patients with recurrent major depressive disorder (MDD) who have responded to acute treatment with antidepressants (AD). However,...

Full description

Bibliographic Details
Main Authors: Huibers Marcus JH, Peeters Frenk PML, de Jong Peter J, Stant A Dennis, Buskens Erik, Ormel Johan, de Jonge Peter, van Rijsbergen Gerard D, Elgersma Hermien J, Bockting Claudi LH, Arntz Arnoud, Muris Peter, Nolen Willem A, Schene Aart H, Hollon Steven D
Format: Article
Language:English
Published: BMC 2011-01-01
Series:BMC Psychiatry
Online Access:http://www.biomedcentral.com/1471-244X/11/8
_version_ 1828844348842704896
author Huibers Marcus JH
Peeters Frenk PML
de Jong Peter J
Stant A Dennis
Buskens Erik
Ormel Johan
de Jonge Peter
van Rijsbergen Gerard D
Elgersma Hermien J
Bockting Claudi LH
Arntz Arnoud
Muris Peter
Nolen Willem A
Schene Aart H
Hollon Steven D
author_facet Huibers Marcus JH
Peeters Frenk PML
de Jong Peter J
Stant A Dennis
Buskens Erik
Ormel Johan
de Jonge Peter
van Rijsbergen Gerard D
Elgersma Hermien J
Bockting Claudi LH
Arntz Arnoud
Muris Peter
Nolen Willem A
Schene Aart H
Hollon Steven D
author_sort Huibers Marcus JH
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Maintenance treatment with antidepressants is the leading strategy to prevent relapse and recurrence in patients with recurrent major depressive disorder (MDD) who have responded to acute treatment with antidepressants (AD). However, in clinical practice most patients (up to 70-80%) are not willing to take this medication after remission or take too low dosages. Moreover, as patients need to take medication for several years, it may not be the most cost-effective strategy. The best established effective and available alternative is brief cognitive therapy (CT). However, it is unclear whether brief CT while tapering antidepressants (AD) is an effective alternative for long term use of AD in recurrent depression. In addition, it is unclear whether the combination of AD to brief CT is beneficial.</p> <p>Methods/design</p> <p>Therefore, we will compare the effectiveness and cost-effectiveness of brief CT while tapering AD to maintenance AD and the combination of CT with maintenance AD. In addition, we examine whether the prophylactic effect of CT was due to CT tackling illness related risk factors for recurrence such as residual symptoms or to its efficacy to modify presumed vulnerability factors of recurrence (e.g. rigid explicit and/or implicit dysfunctional attitudes). This is a multicenter RCT comparing the above treatment scenarios. Remitted patients on AD with at least two previous depressive episodes in the past five years (n = 276) will be recruited. The primary outcome is time related proportion of depression relapse/recurrence during minimal 15 months using DSM-IV-R criteria as assessed by the Structural Clinical Interview for Depression. Secondary outcome: economic evaluation (using a societal perspective) and number, duration and severity of relapses/recurrences.</p> <p>Discussion</p> <p>This will be the first trial to investigate whether CT is effective in preventing relapse to depression in recurrent depression while tapering antidepressant treatment compared to antidepressant treatment alone and the combination of both. In addition, we explore explicit and implicit mediators of CT.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1907">NTR1907</a></p>
first_indexed 2024-12-12T21:03:53Z
format Article
id doaj.art-47b4a124ab7b422eb433a599fb36e757
institution Directory Open Access Journal
issn 1471-244X
language English
last_indexed 2024-12-12T21:03:53Z
publishDate 2011-01-01
publisher BMC
record_format Article
series BMC Psychiatry
spelling doaj.art-47b4a124ab7b422eb433a599fb36e7572022-12-22T00:12:04ZengBMCBMC Psychiatry1471-244X2011-01-01111810.1186/1471-244X-11-8Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressantsHuibers Marcus JHPeeters Frenk PMLde Jong Peter JStant A DennisBuskens ErikOrmel Johande Jonge Petervan Rijsbergen Gerard DElgersma Hermien JBockting Claudi LHArntz ArnoudMuris PeterNolen Willem ASchene Aart HHollon Steven D<p>Abstract</p> <p>Background</p> <p>Maintenance treatment with antidepressants is the leading strategy to prevent relapse and recurrence in patients with recurrent major depressive disorder (MDD) who have responded to acute treatment with antidepressants (AD). However, in clinical practice most patients (up to 70-80%) are not willing to take this medication after remission or take too low dosages. Moreover, as patients need to take medication for several years, it may not be the most cost-effective strategy. The best established effective and available alternative is brief cognitive therapy (CT). However, it is unclear whether brief CT while tapering antidepressants (AD) is an effective alternative for long term use of AD in recurrent depression. In addition, it is unclear whether the combination of AD to brief CT is beneficial.</p> <p>Methods/design</p> <p>Therefore, we will compare the effectiveness and cost-effectiveness of brief CT while tapering AD to maintenance AD and the combination of CT with maintenance AD. In addition, we examine whether the prophylactic effect of CT was due to CT tackling illness related risk factors for recurrence such as residual symptoms or to its efficacy to modify presumed vulnerability factors of recurrence (e.g. rigid explicit and/or implicit dysfunctional attitudes). This is a multicenter RCT comparing the above treatment scenarios. Remitted patients on AD with at least two previous depressive episodes in the past five years (n = 276) will be recruited. The primary outcome is time related proportion of depression relapse/recurrence during minimal 15 months using DSM-IV-R criteria as assessed by the Structural Clinical Interview for Depression. Secondary outcome: economic evaluation (using a societal perspective) and number, duration and severity of relapses/recurrences.</p> <p>Discussion</p> <p>This will be the first trial to investigate whether CT is effective in preventing relapse to depression in recurrent depression while tapering antidepressant treatment compared to antidepressant treatment alone and the combination of both. In addition, we explore explicit and implicit mediators of CT.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1907">NTR1907</a></p>http://www.biomedcentral.com/1471-244X/11/8
spellingShingle Huibers Marcus JH
Peeters Frenk PML
de Jong Peter J
Stant A Dennis
Buskens Erik
Ormel Johan
de Jonge Peter
van Rijsbergen Gerard D
Elgersma Hermien J
Bockting Claudi LH
Arntz Arnoud
Muris Peter
Nolen Willem A
Schene Aart H
Hollon Steven D
Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants
BMC Psychiatry
title Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants
title_full Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants
title_fullStr Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants
title_full_unstemmed Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants
title_short Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants
title_sort disrupting the rhythm of depression design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants
url http://www.biomedcentral.com/1471-244X/11/8
work_keys_str_mv AT huibersmarcusjh disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT peetersfrenkpml disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT dejongpeterj disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT stantadennis disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT buskenserik disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT ormeljohan disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT dejongepeter disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT vanrijsbergengerardd disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT elgersmahermienj disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT bocktingclaudilh disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT arntzarnoud disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT murispeter disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT nolenwillema disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT scheneaarth disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants
AT hollonstevend disruptingtherhythmofdepressiondesignandprotocolofarandomizedcontrolledtrialonpreventingrelapseusingbriefcognitivetherapywithorwithoutantidepressants